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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001133 |
Purpose
In this study, the protease inhibitors indinavir (IDV) and ritonavir (RTV) will be studied in patients who have high levels of virus while taking other protease inhibitors. The purpose of this study is to see how the body takes in, distributes, and gets rid of IDV and RTV. This study will also look at any side effects that IDV or RTV causes.
IDV is an effective anti-HIV drug, but it can be difficult for patients to take. For IDV to work against HIV, it must be taken 3 times a day at a high dose and with a certain diet. Doctors believe IDV may be easier to take if it is given with RTV. Patients who take IDV and RTV together may be able to take IDV only twice a day and at a lower dose. This study will gather information about the safety and side effects of using IDV and RTV together.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Dose Comparison, Pharmacokinetics Study |
| Official Title: | A Phase I/II, Randomized, Open-Label Study of the Safety and Pharmacokinetics of Indinavir + Ritonavir Therapy in HIV-Infected Subjects Failing Amprenavir, Nelfinavir, Saquinavir, or Nelfinavir/Saquinavir Combination Therapy |
| Estimated Enrollment: | 50 |
IDV, a protease inhibitor, has shown excellent clinical and virologic responses when combined with 2 nucleoside analogues. Although effective, the pharmacokinetics of IDV make it difficult to use in many patients. The drug has a short half-life and requires administration in high doses every 8 hours with significant dietary restrictions. Research has shown that IDV kinetics can be improved significantly by the addition of RTV, allowing for administration of IDV at lower doses every 12 hours. The half-life of IDV is prolonged 3- to 5-fold when administered with RTV. Based on these results, it is reasonable to study this combination as a twice-daily dosing regimen.
Patients are randomized to receive 1 of 2 doses of IDV/RTV for 24 weeks (Arms A and B). All patients also receive 2 nucleoside reverse transcriptase inhibitors (NRTIs). The NRTIs are not provided by the study. Clinical assessments take place at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 which includes a virology assessment. [AS PER AMENDMENT 4/21/00: Patients who experience a confirmed virologic failure (defined in protocol) and elect to remain on study treatment, are followed through Week 24. Patients who experience a confirmed virologic failure and elect to discontinue study treatment will have a final evaluation at the time of treatment discontinuation.] Patients are hospitalized for 12 hours at the Week 2 study visit for an intensive pharmacokinetic analysis.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Univ of California / San Diego Treatment Ctr | |
| San Diego, California, United States, 921036325 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| Marin County Specialty Clinic | |
| San Rafael, California, United States, 94903 | |
| Univ of California, San Diego | |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| Denver Dept of Health and Hosps | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Illinois | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| Methodist Hosp of Indiana / Life Care Clinic | |
| Indianapolis, Indiana, United States, 46202 | |
| Division of Inf Diseases/ Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| Wishard Hosp/Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New York | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| Chelsea Ctr | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| United States, Ohio | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 452670405 | |
| United States, Pennsylvania | |
| Univ of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Univ of Pennsylvania at Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Texas | |
| Univ of Texas Galveston | |
| Galveston, Texas, United States, 775550435 | |
| Univ of Texas, Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75390 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 98104 | |
| Puerto Rico | |
| Univ of Puerto Rico | |
| San Juan, Puerto Rico, 009365067 | |
| Study Chair: | John G. Gerber | |
| Study Chair: | Edward P. Acosta |
More Information
| Study ID Numbers: | ACTG A5055, AACTG A5055 |
| Study First Received: | January 17, 2000 |
| Last Updated: | September 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001133 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Dose-Response Relationship, Drug Drug Therapy, Combination HIV Protease Inhibitors Ritonavir |
Indinavir Anti-HIV Agents Pharmacokinetics Treatment Experienced |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Indinavir Molecular Mechanisms of Pharmacological Action Saquinavir Infection Anti-Bacterial Agents Amprenavir Anti-Retroviral Agents Therapeutic Uses Nelfinavir Retroviridae Infections RNA Virus Infections HIV Protease Inhibitors |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Antibiotics, Antitubercular Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections Antitubercular Agents |